FDA.reportPublic FDA data

Neoflex

Primary DI
00850013242559
Brand
Neoflex
Company
CYPRESS ADAPTIVE, LLC
Model
CA700-FP-T15
Catalog number
CA700-FP-T15
Device description
Prosthetic suspension sleeve with knee pad reinforcement in tan color and size 1.5.
Published
2019-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013242559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013242559008500132425598500132425590850013242559

GMDN Terms#

Term, Definition table
TermDefinition
Prosthesis suspension systemA group of devices used to hold/fasten a prosthesis to the body. The devices include locking pins, belts, silicone or neoprene sleeves, wedges, clamps, and suction sockets.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080277500
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013242092Aria safety barb (US)CA300-ASBCA300-ASB2019-12-17
00850013242108Aria Safety Barb (metric)CA300-ASBMCA300-ASBM2019-12-17
00850013242894Aria Universal Mini Valve Molding DummyCA100-MVDCA100-MVD2023-10-05
00850013242887Aria Universal Mini Valve KeyCA100-MVK2022-10-01
00850013242016Aria Mini ValveCA100-MVCA100-MV2021-08-11
00085001342106Aria Mini ValveCA100-MVCA100-MV2021-08-11
00850013242009Aria Valve (US)CA200-AVCA200-AV2019-12-17
00850013242023Aria valve (metric)CA200-AVMCA200-AVM2019-12-17
00850013242030Aria Valve Plus (US)CA200-AVPCA200-AVP2019-12-17
00850013242047Aria valve plus (metric)CA200AVPMCA200AVPM2019-12-17
00850013242054Aria E-valveCA200-AECA200-AE2019-12-17
00850013242061Aria plate valveCA300-APVCA300-APV2019-12-17
00850013242078Aria HV Plate Valve CA300-AHVPCA300-AHVP2019-12-17
00850013242085Aria Hybrid ValveCA300-HYVCA300-HYV2019-12-17
00850013242115Aria AK ValveCA100-AKCA100-AK2019-12-17
00850013242122Aria AK valve insertCA100-VICA100-VI2019-12-17
00850013242139Cypress 4-hole tie-in plateCA400-TIPCA400-TIP2019-12-17
00850013242146Cypress low profile 4-hole tie-in plateCA400-LPCA400-LP2019-12-17
00850013242153Aria auto expulsion valve insertCA400-VCA400-V2019-12-17
00850013242160Aria HV Valve insert CA400-HVCA400-HV2019-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650532Lumo Socket A-1macu4 GmbHISS2026-07-18
04262429650549Lumo Socket A-2macu4 GmbHISS2026-07-18
04262429650556Lumo Socket A-3macu4 GmbHISS2026-07-18
04262429650624Lumo Socket A-4macu4 GmbHISS2026-07-18
04262429650631Lumo Socket B-1macu4 GmbHISS2026-07-18
04262429650891Lumo Socket B-2macu4 GmbHISS2026-07-18
04262429650907Lumo Socket B-3macu4 GmbHISS2026-07-18
04262429650914Lumo Socket B-4macu4 GmbHISS2026-07-18
04262429650921Lumo Socket C-1macu4 GmbHISS2026-07-18
04262429650938Lumo Socket C-2macu4 GmbHISS2026-07-18
04262429650945Lumo Socket C-3macu4 GmbHISS2026-07-18
04262429650952Lumo Socket C-4macu4 GmbHISS2026-07-18
04262429650969Lumo Socket D-1macu4 GmbHISS2026-07-18
04262429650976Lumo Socket D-2macu4 GmbHISS2026-07-18
04262429650983Lumo Socket D-3macu4 GmbHISS2026-07-18
04262429650990Lumo Socket D-4macu4 GmbHISS2026-07-18
04262429651003Lumo Socket E-1macu4 GmbHISS2026-07-18
04262429651010Lumo Socket E-2macu4 GmbHISS2026-07-18
04262429651027Lumo Socket E-3macu4 GmbHISS2026-07-18
04262429651034Lumo Socket F-1macu4 GmbHISS2026-07-18
04262429651041Lumo Socket F-2macu4 GmbHISS2026-07-18
04262429651058Lumo Socket F-3macu4 GmbHISS2026-07-18
04262429651065Lumo Socket F-4macu4 GmbHISS2026-07-18
04262429651072Lumo Socket E-4macu4 GmbHISS2026-07-18
04262429650563Lumo Spacer, STD-Amacu4 GmbHISS2025-11-23
04262429650648Lumo Module Connectormacu4 GmbHISS2025-11-23
04262429650655Lumo Spacer, STD-Bmacu4 GmbHISS2025-11-23
04262429650662Lumo Spacer, STD-Cmacu4 GmbHISS2025-11-23
04262429650679Lumo Spacer, STD-Dmacu4 GmbHISS2025-11-23
04262429650686Lumo Spacer, STD-Emacu4 GmbHISS2025-11-23